510(k) K935139

FASCINATION CERAMIC BRACKET by Dentauraum, Inc. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1994
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type